Medical Bipolar Electrode Assembly With A Cannula Having A Bipolar Active Tip And A Separate Supply Electrode And Medical Monopolar Electrode Assembly With A Cannula Having A Monopolar Active Tip And A Separate Temperature-Transducer Post

ABSTRACT

An electrosurgical system preferably used for denervation procedures of nerve tissue has a control unit and a pluggable electrode assembly. The electrode assembly has a preferably disposable cannula and a preservable supply electrode assembly. The cannula has a tubular body that projects axially from a preferably pointed distal end for piercing tissue to a proximal end engaged to a first coupling assembly of the cannula. The body carries a first contact exposed directly to the nerve tissue and connected electrically to a terminal of the first coupling assembly. The supply electrode assembly has a second coupling assembly and a supply electrode that projects axially and removably into a through-bore of the body when the tool is in an operating state. The second coupling assembly carries a terminal that abuts the first coupling assembly when the coupling assemblies are mated. Preferably the supply electrode carries a temperature sensor for temperature measurement of the targeted tissue and processing by the control unit. Preferably, the electrode assembly also includes a stylet having a rod that fits into the through-bore of the body when the supply electrode assembly is removed and the tool is in a tissue penetrating state.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119 from U.S.Provisional Patent Application No. 60/676,092, filed Apr. 29, 2005, theadvantages and disclosure of which is hereby incorporated by reference.

FIELD OF THE INVENTION

This invention is related generally to an electrode assembly such as anelectrode assembly that can be used to perform a denervation procedure.One version of this invention is related to a bipolar electrode assemblythat can further be employed to introduce therapeutic agents at the siteto which the electrode is applied.

BACKGROUND OF THE INVENTION

Electrosurgical tool systems are used to cut tissue, shape tissue,coagulate tissue and ablate tissue at surgical sites to which the toolsare applied. Generally, an electrosurgical tool system includes anelectrode with at least one electrically active tip. An electrode thathas a single active tip is referred to as monopolar. An electrode withat least two active tips is typically referred to as bipolar. A controlconsole, also part of the system, supplies an RF signal to theelectrode. Often this signal is between 50 KHz and 10 MHz. The RF signalis applied to the active tip(s). If the system includes the monopolarelectrode, a second dispersive electrode, is placed in contact with thepatient to serve as a return path for the RF signal. If the systemincludes a bipolar electrode, the active tips alternate as active andreturn poles during the RF cycle.

One medical specialty in which electrosurgical tools are used withincreasing frequency is pain management. Pain is felt as a consequenceof first, a stimulus being applied to a first nerve. Then, a signalrepresentative of the pain is transmitted from the first nerve throughthe other nerves in the neural network to the brain. An individual cansuffer chronic pain if the biological conditions are such that the firstnerve latches into a condition in which it continually transmits thepain signal through the al network to the brain.

In a pain management process, an electrosurgical tool is used to removeeither the initial pain transmitting nerve or one of the associateddownstream nerves from the neural network. This disconnection stops theflow of pain messages to the brain. Medically, the process of removingthe nerve from the nerve network is call denervation.

In a denervation process, the RF energy emitted by the electrode isapplied to the nerve. The nerve absorbs this energy and, as aconsequence, is heated to the level at which it ablates.

Presently, the common practice is to use a monopolar electrode assemblyto apply the RF energy to the nerve that is to be subjected to ablation.The electrode assembly has two separate components, a cannula and asupply electrode. The cannula is a tube like structure. At the distalend tip, the end positioned at the surgical site, there is an activeelectrode tip. The supply electrode is inserted in the bore that extendsthrough cannula. Fitted to the supply electrode is a temperaturesensitive transducer.

In the denervation procedure, the surface location above nerve to beablated is first anesthesized. The cannula is then inserted through theskin and directed toward the nerve. The supply electrode is fitted tothe cannula. A low powered signal is then applied to the supplyelectrode. This electrode assembly is thus used as a supply electrode toprecisely identify the position of the nerve. Once the position of thenerve is determined, the supply electrode is withdrawn from the cannula.An anesthesia is introduced through the cannula to the procedure site inorder to numb the tissue at the site. The supply electrode is thenreinserted into the cannula. At this time, a higher powered signal isapplied through the supply electrode to the active tip integral with thecannula. These high powered RF signals are what are absorbed by andcause the ablation of the nerve.

During the ablation process, the transducer provides an indication ofthe temperature of the tissue being subjected to ablation. The medicalpersonnel use this information to regulate the application of power tothe electrode assembly.

There are many situations however wherein it is desirable to use abipolar electrode in order to apply RF energy in order to perform thedenervation procedure. This is because, the energy flow when using thistype of electrode is essentially between the two active tips. Thus theenergy flow at the surgical site is more directed than when a monopolarelectrode with a large area external ground pad is employed. As aconsequence of this more directed energy flow, more energy is applied ina shorter amount of time to the tissue, the nerve, to be ablated.Inversely, less energy is absorbed by nearby tissue that should besubjected to ablation. Thus, using a bipolar electrode to perform theablation process would further result in a denervation process that isless likely to harm surrounding tissue.

However, to date, there have been obstacles to using bipolar electrodesfor denervation procedures. This is because it has proven difficult toprovide bipolar electrode assemblies that are relatively small in size.Small diameter electrodes are needed in order to ensure the precisionapplication of the RF energy to the nerve to be ablated. Also, it isdesirable to design the electrode so that when inserted into thepatient, the skin is exposed to minimal trauma. Large diameterelectrodes, with sections having different stepped outer diameters,could potentially cause aggravated trauma to the skin and underlyingtissue during the insertion process.

One could provide a bipolar electrode assembly that is solid. Such anassembly would be small in diameter. However, such an assembly would notprovide the through bore desirable for introducing anesthesia or agentsto the surgical site.

Further different sized and shaped electrode assemblies are available tosurgeons. These different sizes and shapes facilitate the position oftheir distal end tips at the locations where they are to be used toperform treatment. Sometimes the cannulae and supply electrodes appearto match when, in fact, they do not. This requires the medical personnelto take additional time to ensure that the proper cannula and supplyelectrode pair are assembled together to form the electrode assembly.

SUMMARY OF THE INVENTION

This invention is directed to a new and useful electrode assembly. Manypreferred versions of this invention are constructed as bipolarelectrodes. The electrode assembly of this invention is further designedto function as conduit through which anesthesia or other agents can beintroduced to the surgical site.

In some versions of this invention, the electrode assembly includes acannula and a supply electrode. In many versions of this invention, thecannula has two electrically spaced active contacts. The supplyelectrode is dimensioned for insertion in the cannula.

In versions of this invention wherein the cannula has the two tips, thecannula and supply electrode are further constructed, so that as resultof the insertion of the supply electrode into the cannula, twoconductive paths between the cannula and the control console areestablished. The first path is through the supply electrode to a firstone of the active contacts. The second path is established acrosscomplimentary conductors on the cannula and the supply electrode to thesecond active contact of the cannula.

In alternative versions of the invention, the electrode assemblyconsists of a cannula and a complementary post. A temperature sensitivetransducer is disposed at the distal end of the post. In these electrodeassemblies of the invention, the complementary contacts at the proximalend of the cannula and the post establish the electrical path to theactive contact.

A memory device, such as a NVRAM or RFID, is integrally attached to eachcannula and supply electrode or post. Each memory device contains dataidentifying the type of cannula, supply electrode or post and itscharacteristics. Data regarding the operation of the cannula or supplyelectrode are also stored in the memory. Each memory device integralwith a cannula contains data identifying the supply electrodes or supplyelectrode characteristics with which the cannula can be used. Eachmemory device integral with a supply electrode contains data identifyingthe cannulae or cannulae characteristics with which the supply electrodecan be used.

A cannula and supply electrode subassembly is connected to the controlconsole. Internal to the control console is a controller. The controllerreads the data in the memories of the attached cannula and supplyelectrode/post. Based on these data, the controller determines if thecannula-supply electrode or cannula-post assembly will functionproperly. Based on this determination, the control console selectivelydirects the control console to output to the supply electrode the RFsignal needed to perform the intended surgical procedure.

If the cannula and supply electrode (post) are improperly matched, thecontrol console generates a warning message and/or inhibits theoutputting of the RF signal.

Based on the data read from the cannula supply electrode memories, thecontrol console also regulates the RF signal that is applied to thesupply electrode in order to energize the cannulae active tip(s).

In some versions of the invention, when a supply electrode or post isfirst selected for use, the control console generates informationindicating which complementary cannulae can be used with the selectedsupply electrode or post. This makes it easier for surgical personnel toquickly determine which complementary component should be selected foruse with the selected component.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of this invention willbe apparent from the following detailed description of the preferredembodiment and best mode, appended claims, and accompanying drawings inwhich:

FIG. 1 is a perspective view of a bipolar electrosurgical systemembodying the present invention;

FIG. 2 is an exploded perspective view of an electrode assembly of thesystem having a cannula, a stylet, a syringe and a supply electrode;

FIG. 3 is a perspective view of the stylet inserted in the cannuladesignating the tool in a tissue penetrating state of the system;

FIG. 4 is a perspective view of the syringe mounted to the cannuladesignating the tool in an anesthetic state;

FIG. 5 is a perspective view of the supply electrode inserted in thecannula designating the tool in an operational state;

FIG. 6 is an exploded perspective view of the cannula;

FIG. 7 is a top view of the cannula with a terminal removed to showinternal detail;

FIG. 8 is a cross section of the cannula taken along line 8-8 of FIG. 7;

FIG. 9 is a trailing end view of the cannula;

FIG. 10 is an exploded perspective view of the supply electrodeassembly;

FIG. 11 is a partial top view of the electrode assembly in theoperational state;

FIG. 12 is a partial cross section of the electrode assembly taken alongline 12-12 of FIG. 11;

FIG. 13 is a top view of the tool in the tissue penetrating state withthe terminal of the cannula removed to show internal detail;

FIG. 14 is a cross section of the tool in the tissue penetrating statetaken alone line 14-14 of FIG. 13;

FIG. 15 is an enlarged, partial, cross section of the electrode assemblyin the operational state taken from circle 15 of FIG. 12;

FIG. 16 is an end view of the electrode assembly in the operationalstate;

FIG. 17 is an enlarged, partial, cross section of the supply electrodeassembly taken from circle 17 of FIG. 10;

FIG. 18 is a perspective view of the terminal of the cannula;

FIG. 19 is a section view through the supply electrode taken along line19-19 of FIG. 17;

FIG. 20 is block diagram of the electrically active components of theelectrosurgical tool system of this invention;

FIGS. 21A and 21B depict the data fields within the memory of aremovable component, a cannula or a supply electrode, of the system ofthis invention;

FIGS. 22A-22C collectively form a flow diagram of the process stepsexecuted to actuate the electrosurgical tool system; and

FIG. 23 is a flow diagram illustrating the process steps by which a PIDvalue is generated and how the PID value is employed to regulate thepower generated by the system.

DETAILED DESCRIPTION

I. OVERVIEW

Referring in more detail to the drawings, FIG. 1 illustrates a bipolarelectrosurgical system 20 of the present invention having a controlconsole 22 for generating electrical energy of a controlledradiofrequency. An electrode assembly 24 (also referred to as anelectrosurgical tool or electrode tool) of the system 20 plugs into thecontrol console 22 at one end and delivers the radio frequency (RF)energy to a targeted nerve tissue area of a patient at an opposite end.Preferably, the system 20 has a remotely located controller 26 thatcommunicates with and preferably plugs into the control console 22enabling an operating physician to control multiple functions. Furtheraspects of the control console 22 are disclosed in U.S. patentapplication, serial number 11/112,702, having the same assignee as thepresent invention and incorporated herein by reference in its entirety.

In a pain management procedure, system 20 is used to modify nerve cellsto the point at which they no longer function. This procedure is calleda denervation procedure. In a denervation procedure, the modification ofnerve cells is considered to result in the formation of a lesion. Inother procedures wherein the system of this invention is used to modifyor remove cells, the process is called ablating the tissue. The controlconsole 22 applies preferably temperature-controlled, RF energy intotargeted nerve tissue to the electrode assembly 24. The system may alsobe used in “pulsed mode.” Instead of creating heat lesions, RF energy ispulsed with a duty cycle low enough that tissue temperature rise is keptbelow a level which can kill cells. Pain relief is achieved byinfluencing the nerve tissue through the pulsed E field. It is theorizedthat the intense E field created by the pulsed RF influences geneexpression in the nerves. This changed gene expression provides a painreduction. More specifically, the system 20 may be used for selectivedenervation and tissue destruction procedures that may be performed onthe lumbar, thoracic, and cervical regions of the spinal cord,peripheral nerves, and nerve roots for the relief of pain. Examplesinclude, but are not limited to, Facette Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia,and Rhizotomy.

Referring to FIG. 2, the electrode assembly 24 has a cannula 28 and asupply electrode assembly 36. The cannula 28 and the supply electrodeassembly 36 are preferably separate components that releasably mate toone another during the denervation procedure, and the cannula 28 ispreferably bipolar when electrically active, however, a modification ofthe present invention may also utilize monopolar cannula whenelectrically active. A stylet 30 also seen in FIG. 2 is used to fit thecannula to the surgical site at which the procedure is to be performed.Also shown in FIG. 2 is a syringe 32 and a complementary hypodermicneedle 34. Once the cannula 28 is properly placed, the syringe may beused to introduce anesthesia or another drug at the site at which theprocedure is performed. Needle 34 is sometimes inserted in the cannula28 to function as the conduit for introducing the drug. Thus, whilestylet 30, syringe 32 and needle 34 may be used with assembly 28 of thisinvention, it is understood they are not part of the invention.

As best shown in FIG. 3, the cannula 28 is preferably pre-packaged withthe stylet 32 inserted in the cannula. This orientation of the tool 24is referred to as a staging or insertion state 38. Generally, when inthe insertion state 38, the cannula 28 is best suited to pierce andpenetrate skin and tissue to appropriately position the tool 24 withrespect to a nerve targeted for denervation. Upon completion of thedenervation procedure, the cannula 28 and the stylet 32 are preferablydiscarded. As best shown in FIG. 4, after insertion of the cannula 28into the tissue, the stylet 32 is removed and the syringe 32 is insertedor press fitted to the cannula 28 for localized injection of ananesthetic. This orientation of the tool 24 is generally referred to asthe medication state 40. Once the nerve tissue targeted for denervationand the surrounding area is properly medicated, the syringe 32 isremoved from the cannula 28 and the cannula remains in the tissue. Asbest shown in FIG. 5, after medication the supply electrode assembly 36is attached to the cannula 28 for the conduction of energy to the nervetissue targeted for denervation. This orientation of the tool 24 isreferred to as an operational state 42. When the denervation procedureis completed, the supply electrode assembly 36, unlike the disposablecannula 28, is withdrawn from the cannula for sterilization and reuse.Thus, it should be understood that the electrode of this invention isable to be subjected to a sterilization process so that poststerilization has a sterilization assurance level (SAL) of at least10⁻⁶. This means that there is equal to or less than one chance in amillion that a single viable microorganism is present on the sterilizeditem. This definition of sterile is the definition set forth in theANSI/AAMI ST35-1966, Safe handling and biological decontamination ofmedical devices in health care facilities and nonclinical settings.

During the medication state 40, fluids that may be injected into thetissue via the cannula 28 include fluoroscopic contrast fluids, localanesthetics and steroids. Preferably, the signal emitted by the cannula28 and generated by the control console 22 is a high powered radiosignal having a frequency between 100 kHz and 10 MHz and at power rangeof between 2 to 200 Watts. In a denervation procedure the RF signalemitted by the cannula is typically at a power level of less than 50Watts and more often less 20 Watts.

II. BIPOLAR CANNULA

Referring to FIGS. 6-9 and 15-16, the bipolar cannula 28 has a generallytubular body 29, which is generally a multi-layered needle, projectingaxially forward along an axis 50 from a coupling assembly 44 of thecannula. The coupling assembly 44 has an electrically insulated hub 46that is generally ribbed for gripping by the user or physician. Body 29is mounted to the hub 46 and has a conductive inner tube 48, an innerelectrical insulating sleeve 52, an electrically conductive outer tube54 and preferably an electrical insulating outer sleeve 56. The innertube 48 preferably defines a substantially straight and axial extendingthrough-bore 57 (see FIG. 9), and projects axially forward to a distalend 58. The inner tube 48 is electrically insulated from the outer tube54 by the inner sleeve 52 that is tube shaped. Insulating inner sleeve52 is oriented concentrically to and radially outward from the innertube 48 and projects axially from the hub 46 to a generally annulardistal end 60 located adjacent to and trailing the distal end 58.Because inner insulating sleeve 52 does not extend axially forward asmuch as the inner tube 48, a ring shaped portion of the inner tube 48 atthe most distal end of the tube is exposed to the environment. Thissection of inner tube 48 is the first active contact or electrodeterminal 62 of cannula 28.

Outer tube 54 of the body 29 is spaced radially outward from the innertube 48 by the inner insulating sleeve 52 and preferably projectsaxially forward to a distal end 64. Outer tube distal end 64 is spacedproximally rearward from the inner tube active contact 62. Insulatingouter sleeve 56 is preferably a tubular jacket orientated concentricallyto and radially outward from the outer tube 54 and projecting axiallyfrom the hub 46 to a generally annular distal end 66 located adjacent toand trailing the distal end 64. Because the outer sleeve 56 does notextend axially forward as much as outer tube 54, there is ring shapedexposed section of the sleeve 56 at its distal end 64. This section ofouter tube 54 is the second active contact or electrode terminal 68.When a potential is applied across contacts 62 and 68, a RF energy fielddevelops between the contacts 62, 68 thereby sending a current throughthe tissue and completing the circuit.

The insulating inner and outer sleeves 52, 56 are preferably heatshrinkable tubing made of a polyester or Teflon material having a wallthickness of about 0.0008 inches to 0.0012 inches. With regard to theinner and outer tubes 48, 54, the first active contact 62 of the innertube 48 is preferably the supply or power electrode terminal and thesecond active contact 68 is preferably the return or ground electrodeterminal. However, one skilled in the art would now know that theelectrical charge of the contacts 62, 68 can be reversed. Moreover, thecontrol unit 22 may function to fluctuate polarities.

Referring to FIG. 15, because first active contact 62 and the secondactive contact 68 are separated axially by an insulating ring 69 of theinsulating inner sleeve 52, a current path or energy field 71 isgenerated between the contacts 62, 68 by the control console 22 when thetool 24 is in the operating state 42 thus creating a lesion in thetarget tissue. The size of the lesion can be varied by changing orvarying an axial length of any one of the exposed contacts 62 and 68 orinsulating ring 69 which alters the current path 71. Consequently, asurgeon can select an appropriate cannula 28 that meets his or herparticular needs.

Because physicians are typically familiar with the lesion sizes formedby active tips of monopolar systems unlike the present invention, theaxial spacing of the exposed bipolar contacts 62 and 68 or insulatingring 69 can be referenced as equivalents to known active tip lengths ofmonopolar systems, such that physicians can use the bipolar system 20and get the same results as they may have using a known monopolardevice. Testing has been completed for this purpose with the resultsreproduced as follows: Length (mm) of Contact 62, Ins. Ring EquivalentActive Bipolar Cannula 69, Contact 68 Tip Length (mm) Diameter 2.3, 1.3,9 2.5 20G 3.5, 15, 10 2.5 20G 2, 2, 2 5.0 20G 3.5, 2.5, 6 5.0 20G 2.8,2.8, 2.8 7.5 20G 5, 4, 5 10 20G 6, 5, 6 15 20G

It should be appreciated that the above 20G (20 Gauge) diameter is theouter diameter of the insulating outer sleeve 56. This diameter isexemplary, not limiting. Other cannulae of this invention, bothmonopolar and bipolar, may have outer diameters ranging from 12G to asmaller diameter 26G. For electrode assemblies 36 used for denervationprocedures, the diameter of the cannula 28, which is the diameter of thesupply electrode assembly 36, is preferably 16G or more and morepreferably 18G or more.

Notably, multiple variations of the axial lengths of exposed contacts 62and 68 and ring 69 results in generating similarly sized lesions.Testing shows that having a much longer outer tube exposed contact 68relative to the inner tube contact 62 results in the lesion beingconcentrated about contact 62. “Longer” it is understood here means thatcontact 68 has a length two (2) times or more and often three (3) timesor more than the length of contact 62. If active contacts 62 and 68 areequal in size and insulating ring 69 is of equal length or smaller inlength than a single one of the contacts, during a denervationprocedure, the lesion forms around both contacts and the insulatingring.

To facilitate smooth skin piercing, the inner tube distal end 58 isbeveled or chamfered to a point 70 similar to that of a hypodermicneedle. Furthermore, the distal ends 60 and 66 of the insulating innerand outer sleeves 52, 56 are tapered, (tapers not identified.).Moreover, distal end 64 of the conductive outer tube 54 that formssecond active tip 68 preferably has an annular taper 101 around itsouter distal face (see FIG. 15). This tapering substantially reduces orprevents snagging of tissue upon the cannula when the cannula is beinginserted thus reducing tissue trauma.

It should be recognized alternative means may be employed to minimizethe trauma associated with the insertion of the distal face of outertube 54. Instead of a complete taper, outer tube 54 may be formed with abevel around its outer perimeter. Alternatively, an adhesive, a plasticor a heat shrink wrapper may be positioned immediately forward of thedistal end face of outer tube 54 to form an angled surface thatminimizes the trauma associated with the insertion of the outer tube.

Referring to FIGS. 2 and 6-9, the hub 46 of the coupling assembly 44 ofthe cannula 28 is preferably made of injection molded plastic that maybe molded directly to at least one of the proximal ends of the sleeves52, 56 and tubes 48, 54 or is attached by adhesive. Preferably, the hubhas a counter-bore 72 located rearward of and concentrically to thethrough-bore 57 and defined by a rearward projecting collar 74 of thehub 46. The counter-bore 72 has a funnel portion 76 that tapers radiallyinward and forward toward a trailing opening 78 of the through-bore 57.The counter-bore 72 with the funnel portion 76 assist in guiding a solidrod 80 of the stylet 30, the hypodermic needle 34 of the syringe 32, andthe leading portion of the supply electrode assembly 36 into the smallthrough-bore 57 for the various states 38, 40, 42 of the denervationprocedure.

An alcove 82 in the hub 46 of the cannula coupling assembly 44 opensradially outward and axially rearward. Exposed generally through abottom or window 84 of the alcove 82 defined by the hub 46 is outer tube54. As best shown in FIGS. 6 and 18, a resiliently flexible terminal 86of the coupling assembly 44 seats to the hub 46 and is generally biasedagainst the tube 54 forming an electrical connection. Referring to FIG.18, the terminal 86 has an elongated bowed arm 88 that extends axiallybetween a leading cupped end 90 having a convex surface that is insliding contact with the ground tube 54. A contact pad 93 extendsforward and downwardly from bowed arm 88. Contact pad 93 leads to acurved elbow or resilient pivoting joint 92. Extending axially forwardfrom the elbow 92 and radially inward from the arm 88 is a leg 94 thatrests upon the hub 46 to radially aligning the contact pad 93. Anopposite trailing end or tab 96 projects radially inward from a forwardend of the leg 94 for axial alignment of the terminal 86 with respect tothe axis 50.

During manufacturing of the body 29 of the cannula 28, the inner tube 48is cut to length and the bevel at end 58 is cut to form point 70 thenthe outer tube 54 is cut to length. The inner and outer insulatingsleeves 52, 56 are then preferably cut to an approximate length andslide over the respective inner and outer tubes 48, 54 and preferablyadhered with glue. Since the tubes 52, 56 are preferably of a heatshrink type, the tubes 48, 54 with glued sleeves 52, 56 are individuallysent through a heating coil to shrink and thus seat the sleeves 52, 56to the respective tubes 48, 54. The tubes 48, 54 are then individuallyplaced into a fixture and the appropriate amounts of insulation from thesleeves 52, 56 are stripped off the tubes 48, 54 to expose the requiredaxial lengths of ring-shaped contacts 62, 68.

The leading taper of the heat shrunk tubes 52, 56 is then preferablyformed by applying a mild abrasive material such as light sandpaper tothe sleeves already seated on the tubes. The abrasive may be apaper-backed sand paper that after applied, results in a smooth radialtransition between the sleeves and tubes. The outer sleeve 54 is thenslid axially over the inner tube 52 and the ramped annular bead or taper101 preferably of UV cured adhesive is added between the inner sleeve 52and the outer sleeve 54 to further smooth-out the leading radialtransition of the body 29.

In some versions of the invention, the outer tube 54 has a thinner wallthan that of the inner tube 48. This allows the use of a larger sizedinner tube 48, while maintaining a slim overall dimension of the body29. Preferably, the inner tube 52 after heat shrinking is about 22 gaugeand the outer tube 56 after heat shrinking is about 20 gauge. Theproximal end of the body 29 is then inserted into an axially extendinghole in the hub 46 of the cannula 28 and is connected to the hubpreferably by an adhesive. The distal ends of the insulating tubes 52,56 are then sanded to achieve a taper, thus reducing tissue traumaduring insertion of the body 29 when in use.

Finally, the bowed terminal 86 is inserted into the alcove 82 definedthrough a side of the hub 46. The terminal 86 is positioned such thatits forward distal end 90 is electrically contacting the outer tube 54(the outer tube 54 is exposed in the window 84 to make this contact).Terminal 86 is secured in the window 84 by a dimple and/or adhesiveadded between the leg 96 of the terminal and the hub 46.

Inner and outer tubes 48 and 54, respectively, are preferably formed ofa conductive material, more preferably 304 stainless steel. Insulatingsleeves 52 and 56 are preferably formed of polyester heat shrink (PET).The adhesive used to bond the cannula hub 46 to the body 29 is an UVadhesive, more preferably from the urethane (meth) acrylate class. Thehub 46 may also be bonded using an instant adhesive such as ethylcyanoacrylac.

III. STYLET

As best illustrated in FIG. 2, the rod 80 of the stylet 30 projectsforward from an enlarged head or cap 98 of the stylet 30 and to aleading distal end 100 of the rod 80. Preferably, the rod 80 is made ofa corrosion resistant and flexible metal that resists plasticdeformation such as stainless steel and the cap 98 is made of injectionmolded plastic. When the tool 24 is in the tissue penetrating state 38(see FIGS. 3, 13 and 14), a forward facing stop 102 carried by the cap98 is in contact with a rearward facing stop 104 carried by the hub 46of the cannula 28. This axial alignment of the cannula 28 to the stylet30 when in the tissue penetrating state 38 axially aligns the distal end100 of the solid rod 80 to the distal end 58 of the inner tube or tube48. Preferably, the distal end 100 is chamfered or beveled at an anglesubstantially the same as the angle of the distal end 58.

To assure the bevels of the ends are properly aligned circumferentially,a circumferential indexing feature 106 is carried between the hub 46 ofthe cannula 28 and the cap 98 of the stylet 30. Indexing feature 106preferably has a tab 108 formed unitarily to and projecting forward fromthe cap 98 and snugly into the alcove 82 of the hub 46 radially outwardfrom the terminal 86. With both ends beveled, the combination forms aleading flush face that enhances the ability of the tool 24 to piercethrough tissue when in the tissue penetrating state 38, and withoutintroducing tissue fluids and matter into the through-bore 57 of thebody 29 of device 28. Moreover, with the rod 80 of the stylet 30 in thethrough-bore 57, the rigidity of the body 29 is enhanced for purposes ofpenetration.

A post 110 of the cap 98 projects axially forward and is disposedsubstantially concentrically to the axis 50. During manufacturing, aproximal end of the rod 80 is inserted into a concentric hole in thepost 110 and is preferably secured therein with an adhesive.Alternatively, the cap 98 may be injection molded directly to the rod80. When the stylet 30 is mated to the cannula 28, the post 110 snuglyfits in the counter-bore 72 of the hub 46. Because the post 110 does notproject axially as far as the counter-bore 72, an axial distance orclearance exists between the distal end of the post 110 and the bottomof the counter-bore 72 or hub 46. This clearance reduces the potentialfor shear forces placed upon the rod 80 if the rod and the through-bore50 are slightly laterally mis-aligned. This clearance also assures thatthe cannula 28 and the stylet 30 do not unintentionally un-mate from thetissue penetrating state 38 as a result of any undue shearing force.

IV. SUPPLY ELECTRODE

As seen in FIG. 10 the supply electrode assembly 36 is connected by acable 114 and a plug 112 to the control console 22. Internal to cable114 are a plurality of insulated conductors 115. A supply electrode 118of the electrode assembly 36 extends from a housing 134 attached to theproximal end of cable 114. Generally, the plug 112 removably connects tothe control console 22. The cable 114 extends flexibly between the plug112 and the coupling assembly 116, and the supply electrode 118 issupported by and projects outward from the coupling assembly 116.

The supply electrode 118 serves as the component that completes theconductive path from control console 22 through plug 112 and cable 114,to the first active contact 62 of the cannula 28. Supply electrode 118also functions as a housing for a temperature sensitive transducer 120,here, a thermistor (see FIG. 17). Supply electrode 118 includes anelongated hollow body or shell 122 preferably formed of high strength,electrically conductive material such as stainless steel or a memorymetal such as a nickel-titanium alloy. One potential alloynickel-titanium alloy from which shell 122 can be formed is sold underthe trademark NITINOL. Shell 122 is preferably cylindrical and shapedsuch that, when the supply electrode 118 is inserted in the through-bore57 of the body 29, a substantially cylindrical outer wall 124 of thehollow shell 122 is in physical contact with a substantially cylindricalinner wall of the electrode tube 48. The supply electrode shell 122 isfurther shaped, so that when the supply electrode 118 is fully insertedin the body 29 (i.e. the operational state 42), a sealed distal end 123of the shell 122 of the supply electrode 118 is located at the opendistal end of the through-bore 57 near point 70 of inner tube 48. Oneskilled in the art would now know, however, that completion of theelectrical circuit between the inner tube 48 of the body 29 and thecoupling assembly 116 of the supply electrode assembly 36 could be madewith mating terminals supported by respective coupling assemblies 44,116.

Preferably, the Nitinol shell 122 of the supply electrode 118 is formedfrom a tube with an interior surface of the tube being scrubbed andsmoothed by the flow of a slurry during manufacturing. Polishing of thetube in this way makes it easier to insert the temperature sensor 120into the shell 122. With the interior surface of the tube polished, thetube is cut to length and the distal end 123 is sealed preferably byplasma welding or other appropriate means.

Temperature transducer 120 is a device such as a thermocouple or athermistor. The output signal from transducer 120 is output throughcoupling assembly 116, through cable 114 and into the control console22. This signal provides a temperature reading for the physician. Thetemperature signal may be used as input signal for a feedback controlloop to regulate the characteristics of the RF signal output by console22. In some systems, the physician can use the temperature data tomanually regulate console operation.

Referring to FIGS. 17 and 19, the temperature sensor 120 comprises twoinsulated thermocouple wires 126, 128 preferably of a K-type that eachhave a stripped end leads located at the sealed distal end 123 of theshell 122. Preferably, the wires 126, 128 are coated with Teflon toreduce or prevent any potential for breakage and/or electrical shorts.In one version of the invention K-Type thermocouple wire is employed.The end leads are welded together to form a thermocouple junction 130,shown in phantom in FIG. 19. Thermocouple junction 130 is encased in anelectrically insulating bulb 132. In one version of the invention, bulb132 is formed by coating the thermocouple junction 130 in epoxy. Inpreferred versions of the invention, bulb 132 is relatively thin. Morespecifically, the outer diameter of the bulb does not exceed thecombined outer diameters of the wire insulated wires 126, 128. Duringmanufacturing, once the temperature sensor 120 is formed, the bulb 132of the sensor 120 is seated at the sealed distal end 123 of shell 122with an adhesive, as best shown in FIG. 117. Preferably, bulb 132 seatsagainst the inner surface of the shell 122 at the end 123.

Referring to FIG. 10, the coupling assembly 116 of the supply electrodeassembly 36 has an outer housing 134, a carrier 136, a cartridge 138 andan electrical terminal 140. The outer housing 134 is preferably ribbedfor improved gripping by a physician during use. The housing 134,carrier 136 and cartridge 138 are preferably formed of an electricallyinsulating thermoplastic material, more preferably, polyetheretherketone(PEEK). The housing 134 and cartridge 138 are rigidly secured togetherpreferably by an adhesive. The carrier 136 is generally housed by thehousing 134 and is located axially rearward of the cartridge 138. Theterminal 140 is seated to and supported by the cartridge 138.

Similar to the post 110 of the stylet 30, the carrier 136 has a forwardprojecting post 142 that projects through the cartridge 138 and isdisposed concentric to the axis when in the operation state 42. Shell122 of the supply electrodel 18 is supported by and extends coaxiallythrough the post 110. Preferably, the carrier 136 has a cavity 144located rearward of the post 110 and opened laterally outward for makingand accessing electrical connections during manufacturing. Similar tothe cap 98 of the stylet 30, a circumferential indexing feature 146 andaxial indexing feature 148 are carried between the coupling assembly 44of the cannula 28 and the cartridge 138. Indexing feature 146 has a tab150 projecting forward from the cartridge 138 and snugly into the alcove82 of the coupling assembly 44. Indexing feature 148 is the planarforward facing surface of cartridge 138 with which hub stop 104 aligns.Feature 148 thus limits axial movement of cannula 28 relative to supplyelectrode assembly 36. Tab 150, it should be appreciated alsofacilitates alignment of the cannula upon its decoupling from the supplyelectrode. This reduces shear stresses on the supply electrode so as toincrease the extent to which the supply electrode 36 can be reused.

It should be understood that the cannula 28 and supply electrodeassembly 36 are constructed so that when assembled together to formelectrode assembly 24, the actual supply electrode 118 abuts the innerwall of inner tube 48 that defines bore 57. In one version of theinvention, inner tube 48 is constructed so that bore 57 has a diameterof 0.018 inches and the complementary supply electrode 118 has adiameter of 0.016 inches. Thus, in this construction of the inventionthe surface-to-surface clearance between the cannula inner tube 48 andthe supply electrode 118 is 0.001 inches. In versions of the inventionwherein the supply electrode is made from Nitinol alloy or otherflexible material the clearance between these two components may begreater than this amount. Generally, it is believed the maximumclearance should be 0.010 inches or less and preferably 0.005 inches orless. This should insure that, upon insertion of the supply electrodeinto the inner tube 48, there is sufficient surface contact between thecomponents. Similarly, a minimal surface clearance of 0.0005 inches andmore often 0.001 inches between these components is desirable. Thisminimal clearance facilitates the slidable insertion and removal of thesupply electrode 118 into and out of the cannula 28.

V. MEMORY

Referring to FIGS. 8-10 and 12, preferably adhered in or press fittedinto a pocket in the hub 46 of the coupling assembly 44 of the cannula28 is a non-volatile memory device (NVRAM_(c)) 154. A multi-pincontactor 156 is supported by the cartridge 138 and mates to rearwardprojecting pins of the NVRAM_(c) 154 when the coupling assemblies 44,116 mate. An associated NVRAM_(E) or RFID chip 155 (see FIG. 10 shown inphantom) is preferably housed in the plug 112 and communicates with theNVRAM_(c) 154 and control console 22. The NVRAM_(E) 155 stores data usedto regulate the operation of the supply electrode device 36. Generally,the NVRAM_(c) 154 contains data used to match the cannula 28 to thesupply electrode device 36 and to generally regulate the operation ofthe system 20. The NVRAMs 154, 155 can also be utilized to store datarequired to establish integration and derivative constants for analgorithm of the control console 22 that processes temperature sensed bythe temperature sensor 120.

FIG. 20 illustrates the components internal to control console 22 andtheir relationship to NVRMS 154 and 155. The actual energization signalapplied to the electrode 22 is supplied by an RF signal generator 156internal to the control console 22. The operation of the RF signalgenerator 156 is regulated by a microcontroller or a system ofmicrocontrollers, p controller 160 in Figures. One suitable controlprocessor that can be employed as microcontroller 160 is the PIC18F6720available from Microchip Technology Inc. The microcontroller 160 orsystem of microcontrollers 60 regulates the actuation of the system 20based on surgeon-entered command signals. A generic command input/output(1/0) module 162 receives the surgeon-entered commands from eitherremote controller 26, the screen if the screen is touch screen or anycontrol knobs. The signals generated by 1/0 module 162 are forwarded tothe microcontroller 160. Microcontroller 160 further regulates theoperation of the system 20 based on the data read from the cannulaNVRAM_(c) 154 and the supply electrode NVRAM_(E) 155.

Also internal to control console 22 is a memory 161. Memory 161 storesthe operating instructions executed by the microcontroller 160. Thememory 161 also stores the data read from the NVRAMs 154 and 155 as wellas certain lookup data, discussed below, referenced by themicrocontroller 160. Memory 161 is shown as a generic memory unit. It isunderstood that memory 161 may contain both memory units in which dataare permanently stored and units in which data are temporarily stored.

Cable 114 also contains the conductors that connect NVRAMs 154 and 155to control console 22

Cable 114 extends from the control console 22 to the coupling assembly116 of the supply electrode assembly 36. Internal to cable 114 is aconductor of the plurality of conductors 115 that carries the powersignal generated by RF generator. Cable 114 also contains a conductor ofthe plurality of conductors 115 that functions as a RF return path fromthe coupling assembly 44 of the bipolar cannula 28. Two conductors ofthe plurality of conductors 115 are part of a one wire bus over whichdata are read from and written to the NVRAMs 154, 155. Another two dataconductors of the plurality of conductors 115 are used to transmitanalog signals from the temperature sensor or thermocouple 120 to thecontrol console 22. For simplicity, all of the plurality of conductors115 are not illustrated in FIG. 12. Additional conductors could beprovided to facilitate switching, control, or navigation functionslocated on the supply electrode assembly 36 and/or cannula 28.

The cannula coupling assembly 44 also has a similar terminal orconductor that extends from NVRAM_(c) 154 that terminates at a separatecontact pad. The coupling assembly 116 of the supply electrode assembly36 has contact pads that are complementary to the above two contactpads. The cable conductor that functions as the one-wire data bus isconnected to the contact pad that connects to the cannula NVRAM_(c) 154.Internal to the control console 22 there is a NVRAM reader 164. Theconductor internal of the plurality of conductors 115 forming theone-wire NVRAM data bus is connected to the NVRAM reader 164. The outputdata signals generated by NVRAM reader are supplied as input data to themicrocontroller of the console 22. The analog signal generated bythermocouple 120 is applied to an analog to digital converter 168 alsointernal to control console 22. The digitized output signal fromconverter 168 is another input into the microcontroller 160.

FIGS. 21A and 21B collectively illustrate the types of data stored ineither of the memories internal to NVRAMs 154 and 155. In a name field170 there is data identifying the type of component. This information ispresented on the display integral with the console I/O module 162. Apart number field 172 contains part number data also presented on theconsole display. A revision field 174 contains data indicating therevision or form of the data stored in the NVRAM memory. These data areused by the microcontroller 160 to determine the types of the data inthe subsequent memory fields. The serial number of the component withwhich the NVRAM is integral is stored in field 176. These data may beused to inhibit use of the component. This may be necessary if datareceived from another source informs the control console 22 that theparticular component should not be used. Data in a manufacturer field178 identifies the manufacturer of the component. These data arepresented on the console display.

Data regarding the minimum software and hardware versions of the controlconsole with which the component can be used are stored in fields 182and 184, respectively. These data are used by the control console 22 todetermine whether or not it has the minimum hardware and software tooperate the component. Data in a GUI interface field 186 is used by thedisplay controller to set the appropriate image on the control consoledisplay. A device type data field 188 contains information regarding thetype of component. This information is presented on the display.

Some of the NVRAM data is specific to a particular component. Forexample, NVRAM_(c) 154 integral with the cannula 28 contains a polarityfield 189. The polarity field 189 contains data indicating the polarity(monopolar or bipolar) of the cannula 28. Field 190 contains dataregarding whether or not the component is considered the primary orsecondary component for regulating the operation of the system 20. Field190 is thus referred to as the primary/secondary field. Field 191 is thepartner field. The data in the partner field indicate what othercomponents can be used with this component.

An operating mode field 192 contains data used to indicate theparticular purpose for which the component is designed. For example,data in field 192 may be used to indicate if the component is designedto cut, coagulate or blend tissue. Control console 22 uses the data inoperating mode field 192 to determine the characteristics of theconsole's electrical output.

Other data in the NVRAMs 154 and 155 describe the physical parameters ofthe components with which each NVRAM is integral. A gage field 194contains data indicating the gage, the outer diameter of the component.For the cannula 28, this is the diameter across the outermost outertube, tube 36 in FIG. 2. For the supply electrode assembly 36, this isthe diameter across the electrode shell 122.

NVRAM_(c) 154 integral with the cannula 28 also may contain a number ofcontacts field, field 196. This is because it is possible to provide anelectrode with plural exposed conductive surfaces that simultaneouslyact as a common active contact. Number of contacts field 198 thusindicates the number of active contacts integral with the supplyelectrode or cannula 28. Field 202, the active contact length field,contains data indicating the longitudinal length of the distal mostactive contact, contact 62 of FIG. 14. A contact separation field, field204, indicates the distance between the first active contact 62 and thesecond active contact 68.

Display length data field 204 contains data that indicates the overalllength of the component. Thus, display length field 204, integral withcannula 28 contains data indicating the overall length of the cannula.Display length field 204 internal to a NVRAM_(E) 155 integral with asupply electrode assembly 36 contains data indicating the overall lengthof the electrode shell 122. A physical characteristics field 208contains data indicating certain data regarding the associated componentthat is not numerically quantified. These data, for example, are:whether or not the component is curved; or if the distal end tip of thecomponent is blunt or other shape. Data in the physical characteristicsfield 208 of a cannula NVRAM_(c) 154 also indicates if the most proximalend active tip has a non-circular shape and the nature of the shape, forexample star shaped. Data in the physical characteristics field 208 ofelectrode NVRAM_(E) 155 indicate the type of metal from which theelectrode shell 122 is formed. The data in fields 188-208 are read bymicrocontroller 160 and presented on the console display.

Component NVRAMs 154 and 155 also contain data that regulate theoperation of the component with which the NVRAM is integral. Some ofthese data are stored in feedback loop data field 210. These datainclude proportional integral derivative (PID) values that, as discussedbelow, regulates the operation of the system 20. Additional control dataare stored in a crossover temperature field 212. These data are used todefine a crossover temperature above and at or below which particularfeedback loop constants are employed in the below discussed filteringalgorithm. The NVRAM integral with a reusable component, i.e., thesupply electrode assembly 36, contains an odometer set point field 214.The data in field 214 indicates the number of times the component can beused before it should be subjected to a maintenance overhaul. Field 214may also contain data indicating the maximum overall number of times thecomponent can be used.

Each NVRAM 154 and 155 also contains match data. The match data internalto the cannula NVRAM_(c) 154 identifies the supply electrode assemblies36 with which the cannula 28 can and cannot be used. The match datainternal to the supply electrode NVRAM_(E) 155 identifies the cannulae28 with which the supply electrode assembly 36 can and cannot be used.As discussed below, there are two ways to match a cannula 28 and asupply electrode assembly 36, by part numbers or by characteristics. Thematch data stored in NVRAMs 154 and 155 is used to perform both types ofmatches.

These data include, in a part number field 218, a part number specificto the component with which the NVRAM 154 or 155 is integral, thecannula 28 or the supply electrode assembly 36, respectively. This partnumber identifies the component with regard to the below discussedmatching registry. In some versions of the invention, data in partnumber field 218 is used to perform the below-discussed match process.This eliminates the need to provide a field 218 with identical data.

A match characteristics field 220 contains data that identifies thecharacteristics of the component for matching purposes. For a cannula28, the data in field 130 indicates: if the cannula is monopolar orbipolar; the required length of the complementary electrode; if thecannula is a primary or secondary device; if the cannula requires athermocouple in order to be operated; the temperature range of thethermocouple; the material that is acceptable for the complementaryelectrode; and the necessary gage of the complementary electrode. Thedata in the match characteristics field 220 in an electrode NVRAM_(E)155 is complementary to the above data. Specifically, the data in thefield 220 of NVRAM_(E) 155 includes: an indication regarding whether ornot the electrode can be used with a monopolar or bipolar cannula; thelength of the electrode; if the electrode is a primary or secondarydevice; if the electrode includes a thermocouple; the temperature rangeof the thermocouple; the material from which the electrode shell 122 isformed; and the gage of the electrode main body.

NVRAMs 154 and 155 also include a match table 222 and a lockout table224. The data in the match table 222 identify, by part number, thecomponents with which the component carrying the data can be used. Thedata in field 222 for the cannula NVRAM_(c) 154 identifies the partnumbers of the supply electrodes 36 with which the cannula can be used.The data in field 222 of electrode NVRAM_(E) 155 identifies the partnumbers of the cannulae 28 with which the supply electrode assembly 36can clearly be used. The data in the lockout table 224 of each NVRAM 154and 155 list the part numbers of the companion components with which theparticular component clearly cannot be used.

Some NVRAMs 154 and 155 may also include one or more PID multipliervalues. These data are stored in a PID multiplier field 226. The purposefor these data are discussed below.

NVRAMs 154 and 155 may also contain one or more memory fields in whichdata are written to by the control console 22 to which the associatedcomponent is attached. One of these fields is an odometer field 228.This field is present in the NVRAM of a component that is reusable, suchas a reusable supply electrode 22. This field stores data indicating thenumber of times the particular component was used. In one version of theinvention, odometer field is a multi-bit field. At manufacture or aftercomplete overhaul, all bits are set to “0” or “1“. Each time thecomponent with a NVRAM including field 228 is plugged into the console.The state of the next unflipped bit is inverted.

VI. OPERATION

In operation, the cannula 28 and stylet 30 are supplied from themanufacturer preferably preassembled in the tissue penetration state 38and in a sterile environment or package. Preferably with the guidance ofX-ray or fluoroscopy, the cannula body 29 is inserted in the targetednerve tissue. Once located, the stylet 30 is removed from the cannula 28and discarded.

When connecting the supply electrode assembly 36, the distal end 123 ofsupply electrode 118 is first inserted through the rearward opened bore72. The funnel portion 76 of the bore 72 acts to guide the distal end123 to the small rearward opening of the through-bore 57 generally ofcannula body 29. Once the supply electrode 118 begins insertion into thecannula body, the inner electrode 48 is in electrical contact the outerwall 124 of the shell 122. This contact establishes a conductive linkwith the complementary power conductor in cable 114. The outer electrode54 and associated terminal 86 has yet to make electrical contact withthe terminal 140 of the coupling assembly 116 of the supply electrodeassembly 36, hence, the circuit is not yet completed.

During insertion, the circumferential indexing feature 146 is properlyaligned (i.e. tab 150 aligned to alcove 82). With continued insertion,the post 142 of the supply electrode assembly 36 begins to enter theblind bore 72 of the cannula 28. This substantially aligns the supplyelectrode 118 laterally to the through-bore 57 thus preventing potentialdamage and/or plastic deformation of the supply electrode 118. Also, theforward projecting tab 150 begins to enter the alcove 82 assuring thatthe terminals 86, 140 are circumferentially aligned. Continued insertioncauses the terminal 140 of the supply electrode assembly 36 to abutagainst contact pad 93 of the terminal 86 which in-turn causes the arm88 of terminal 86 to flex or bow further within the alcove 82. Thiscauses the spring or biasing force that presses the terminal end 90against the outer tube 54 to increase providing a reliable electricalconnection.

The axial alignment feature 148 carried between the hub 44 and thecartridge 138 prevents over insertion of the supply electrode 118 intothe cannula 28 and assures that the distal end 123 and temperaturesensor 120 of the supply electrode 118 are consistently located withrespect to the cannula thus providing consistent and reliable operationof the system 20. More specifically, the distal end 123 of the supplyelectrode 118 is located at the distal end of the inner tube 48 of thecannula 28 when the rearward stop 104 carried by the hub 46 abuts theforward or leading stop 152 of the cartridge 138. Assuming cannula 28and supply electrode assembly 36 are properly paired this means thedistal end of the supply electrode shell 122 extends a short distanceforward of the open end of cannula bore 57. For example, in versions ofthe invention wherein the distal end of the cannula inner tube 48 isbeveled, the distal end of supply electrode shell 122 sits in theangular space defined by the beveled face of the cannula. This face in acannula of 20 Gauge size may be in length between 0.065 and 0.090inches.

With the electrode assembly 24 in the operating state 42, pain nervestimulation is conducted (typically 50 Hz DC biphasic pulses) to ensurethe RF energy is applied to the proper pain nerve. Next, motor nervestimulation steps are then taken to ensure destructive energy is notapplied to motor nerves. This process is typically performed by apply asignal at approximately 2 Hz. The signal applied at this point in theprocedure is typically at a power level of 5 Watts or less.

After the nerve is located, it may be desirable to apply a therapeuticfluid or an anesthetic. If therapeutic fluids are needed after thepenetration state 38, system 20 is placed into the medication state 40by preferably press fitting a leading end of the syringe 32 against thecollar 74 and into the bore 72 for slightly pressurized injection of thetherapeutic fluid into the through-bore 57 of cannula body 29. After themedication state 40, the syringe 32 is preferably removed from the hub46 and the supply electrode assembly 36 is connected thus designatingthe operation state 42 of the tool 24.

After the nerve is located and the option therapeutic (anesthetic) agentis applied, the nerve is subjected to the actual denervation procedure.The control console 22 generates the RF or Stimulation signal throughthe shell 122 of the supply electrode 118. The inner tube first activecontact 62 functions as the active electrode and the second activecontact 68 of the outer tube 54 functions as the return electrode. TheRF signals emitted from the first active contact 62 flow through thetissue and return to the control console through the second activecontact 68. A fraction of the energy in the RF signals is absorbed bythe tissue. This RF energy is converted to thermal energy in order tocause the desirable therapeutic effect, the formation of a lesion;tissue ablation; or disruption of the cellular electrochemicalstructure.

Upon completion of the denervation procedure, cannula 28 is preferablydiscarded and the supply electrode assembly 36 is sterilized andpreserved for reuse.

It should be appreciated that the bipolar version of this inventionmeans that the need to use the ground pad of a monopolar assembly iseliminated. The elimination of the ground pad means can, for someprocedures, reduce complexity. Further the cost associated withproviding the ground pad is eliminated.

It should also be appreciated that the cannula 28 and electrode assembly36 is preferably used in conjunction with the control console 22 tocreate radio frequency (RF) lesions in nerve tissue. The control console22 applies temperature-controlled, RF energy into targeted nerve tissuevia the supply electrode 118. This energy destroys the nerve tissue'sability to conduct electrical signals. Pain relief is achieved bycreating defined lesions on pain-conducting nerve fibers or tissue. Thesystem may also be used in “pulsed mode.” Instead of creating heatlesions, RF energy is pulsed with a duty cycle low enough that tissuetemperature rise is kept below a level which can kill cells. Pain reliefis achieved by influencing the nerve tissue through the pulsed E field.It is theorized that the intense E field created by the pulsed RFinfluences gene expression in the nerves. This changed gene expressionprovides a pain reduction.

Operation of the system 20 with regards to NVRAMs 154, 155 is nowdescribed wherein the control console 22 is initially actuated.Initially, the control console 22 is actuated as represented by step250. While not illustrated, it should be understood that, as part of theinitialization step 250, microcontroller 160 performs a self-test on theother components of the control console 22. If the self-test detects afault state, appropriate data are presented on the I/O module 162.

Microcontroller 160, in step 252, then causes the 1/0 module 162 topresent an image inviting the surgical personnel to identify if aspecific doctor and/or specific procedure is going to be performed. If,in step 254, such data are entered, microcontroller 160 retrieves fromthe console memory any stored data specific to the doctor and/orprocedure, step 256 e. These data, for example, may include initialand/or maximum temperature settings preferred by the doctor. Additionaldoctor or procedure preference data includes duration of treatment,waveform optimization, or electrical stimulation data. These data arethen used later to control the operation of the system 20.

The next step in the operation of the system, step 258, is theattachment of the supply electrode 36. This is performed by the couplingof the electrode coupling assembly 116 to cable 114.

Once the supply electrode assembly 36 is attached, the data in theelectrode NVRAM_(E) 155 are read, step 260. As is known in the art, oncethe control console 22 is initialized, microcontroller 160 periodicallyinstructs the NVRAM reader 164 to send out interrogation signals. Aslong as no components are attached to cable 114, no response to thesesignals are received. Once a supply electrode assembly 36 is attached,the electrode NVRAM_(E) 155 sends out a brief acknowledgement to thebasic interrogation. When this response is received, NVRAM reader 164,in turn, reads out all of the data in the NVRAM_(E) 155. These data arethen forwarded to microcontroller 160.

Microcontroller 160 then, in step 262, determines if the supplyelectrode assembly 36 is on a basic lockout list and should not be used.As part of the lockout testing, microcontroller determines, by referenceto data in the minimum software and hardware revision fields 178 and184, respectively, if the control console has the minimum software andhardware to actuate the electrode. As part of step 262, microcontroller160 also determines if the serial number of the electrode from field 176is in a table of lockout components. This table is stored in the controlconsole memory 161. The data in the table are updated by a networkconnection to the control console 22 or an update to the systemsoftware. Thus, in the event the manufacturer determines there is areason not to use a specific lot of manufactured components, the serialnumber data for the components are forwarded over the network connectionto the control console 22 and stored in the component lockout tableinternal to memory 161.

If, in step 262, it is determined the attached electrode should not beused, microcontroller 160 causes an appropriate warning message to bepresented on the I/O module 162, step 264. Surgical personnel shouldthen remove the attached electrode (step not shown). A new supplyelectrode assembly 36 is attached; step 258 is reexecuted.

If in, step 262, it is determined the electrode 22 is available for use,microcontroller 160, in step 266, displays on the I/O module 162 datathat describes the characteristics of the electrode. These data are thedata read from the name, part number and physical characteristics fields170, 172, 192, 194, 196, 198, 202 and 204 of the NVRAM_(E) 155.

In a step 268, the microcontroller 160 also causes to be presented onthe display of the I/O module 262 information regarding suitablecannulae 28 that can be matched with the supply electrode assembly 36.These information include part numbers of acceptable cannulae based onthe data in the match table 222 from NVRAM_(E) 155. The information alsoincludes the characteristics of specific matchable cannulae. These dataare the data contained in the match characteristics field 220 ofNVRAM_(E) 155

Based on the match data presented on the I/O module 162, the surgicalpersonnel, in step 270, select an appropriate cannula 28 and attach itto the system 20. The selected cannula is fitted over the electrode mainbody 46 so that the cannula hub 46 couples to the electrode couplingassembly 116. Then, in step 272, the data in the cannula NVRAM_(c) 154are read. The reading of the data in the cannula NVRAM_(c) 154 occursbecause, even though, the supply electrode assembly 36 and NVRAM_(E) 155are attached to the control console 22, the NVRAM reader 164 continuesto send out basic interrogation signals. Once the data in the electrodeNVRAM_(E) 155 are read, NVRAM_(E) 155 is instructed to periodically notto respond to a basic interrogation signal. During the time periods inwhich NVRAM_(E) 155 is silent, NVRAMc 154 responds to the basicinterrogation signal. Once the basic response is received, NVRAM reader164 reads the data in NVRAM_(c) 154.

Once the data in NVRAM_(c) 154 are read, microcontroller 160 determinesif the cannula 24 meets minimum use criteria for the rest of the system20, step 174. In step 274, which is similar to step 262, a basicdetermination is made regarding if it is appropriate to use the cannula24 with the control console 22. These determinations are based on thecannula minimum software and hardware revision requirements and thecannula serial or lot number.

Also as part of step 274, the data in the cannula odometer field 228 ischecked. If the data in this field and in the limits field 124 indicatethe cannula 26 is overdue for major maintenance or was used for morethan its useful cycles, microprocessor 60 considers the cannula unusableor displays a warning message to the user.

If, as a result of the evaluation performed in step 274, it isdetermined that the cannula is not appropriate for the rest of thesystem, in step 276, a warning message is presented on the I/O module.In step 276, a message concerning the problems with the cannula ispresented. The surgical personnel then remove the cannula, step notshown, and a new cannula is selected and attached, step 270 isreexecuted.

Once the fundamental determination has been made that it is appropriateto use the cannula 24 with control console 22, the actual matchingprocess starts. This process starts with the basic part number matchdetermination, step 278. In this step, the microcontroller 160determines if the part number for the cannula, from NVRAM_(c) 154 partnumber field 218, is on the table of part numbers from the match table132 for the supply electrode 36. If this determination is positive,microcontroller 160 continues to configure the system for operation,step 284.

If the determination in step 278 is negative, microcontroller 160proceeds to a part number lockout determination, step 280. In step 280,microcontroller 160 determines if the cannula part number is on thelockout table 224 for the attached supply electrode assembly 36. If thisdetermination is positive, microcontroller 160 executes step 276. Duringthis execution of step 276, microcontroller 160 causes an appropriatemessage to be presented on the I/O module 162 explaining why the cannula28 is unsuitable for use.

If in step 280, it is determined that the cannula 28 can potentially beused with the supply electrode assembly 36, a characteristics match step282 is performed. In step 182, microcontroller 160 determines if thecharacteristics of the cannula 28 indicate that it can be used with thesupply electrode assembly 36. Step 282 is performed by comparing thedata from the match characteristics field 130 of the cannula NVRAM_(c)154 to the data from the match characteristics field 130 for the supplyelectrode NVRAM_(E) 155. This determination will indicate that thecannula 28 and supply electrode assembly 36 are compatible if: thecannula and electrode are both intended for monopolar or bipolar use; ifthe electrode is of an appropriate length and gage for the cannula; theelectrode has the appropriate thermocouple 48; and the material fromwhich the electrode main body is formed is appropriate for the cannula.If, in step 282 it is determined that the components are appropriate foreach other, microcontroller 160 proceeds to the configure system step184.

Alternatively, if in step 282 it is determined that the components arenot appropriate for each other, step 276 is executed an appropriatemessage is presented on the I/O module 162.

In step 284, microprocessor 60 configures the system 20 of thisinvention for operation based on the operational data contained inNVRAMs 154 and 155. This includes presenting information on the I/Omodule 162 that represents the attached cannula 28 and supply electrodeassembly 36 sub-assembly.

Microcontroller 160, as part of step 284, establishes initial andmaximum operating temperatures for the cannula 28 and supply electrodeassembly 36 sub-assembly and/or establishes the temperature profile.Power levels and frequency for the signals that are generated by RFgenerator 56 may also be set. Stimulation Values may also be set. Theseoperating parameters may be established based on data in one of theNVRAMs 154 or 155 or based on data in a lookup table in the consolememory 61. If a doctor and/or procedure identifying information wasloaded in step 156, then these parameters are established based on thisretrieved information.

As part of step 284, microcontroller 160 also configures the controlalgorithm for operation. As illustrated in FIG. 23, this algorithmprovides closed-loop control of the generation of power by the system20. Initially, in step 302, as part of this process, the temperature atthe surgical site is measured and supplied to the microcontroller 160.Specifically, the analog signal from thermocouple 120 is applied to theconsole A/D converter 168. Converter 168 generates a digitized versionof the signal. The digitized temperature is forwarded to themicrocontroller 160. Not shown are the steps of correcting and filteringof the temperature signal. Temperature correction may be performed usingan algorithm wherein the correction variables are data retrieved fromthe electrode NVRAM_(E) 155 (fields not shown). The correction variablesare employed as constants in a mono-, bi- or tri-nominal equationspecific to the thermocouple 120. This correction process is performedto eliminate any variations in output signals based on the manufacturingvariations of the thermocouples. Filtering is performed on thetemperature signal to eliminate the effects of any spikes. Variables toregulate the filtering, which may be either infinite impulse response orfinite infinite response filtering, may also be supplied by theelectrode NVRAM_(E) 155.

The corrected and filtered temperature signal is then used in a resetpower step 304 to determine the extent to which the power level of thesignal output by the RF generator 156 should be reset. In step 304,microcontroller 160 employs a proportional integral derivative algorithmto determine the extent to which the RF generator output signal shouldbe reset. The two inputs into this algorithm are the corrected andfiltered temperature signal from thermocouple 48 and the surgeonselected operating temperature for the cannula 28 and supply electrodeassembly 36 subassembly. In FIG. 5, this temperature is shown as beingentered through step 304. It should be appreciated that step 303 isperformed when the system 20 is first actuated and is reexecuted asnecessary by the surgeon. Again, the temperature profile for step 304may come from the preference data loaded in step 256.

Based on the difference between the two temperatures and thebelow-discussed derivative variables, in step 306, microcontroller 160resets the signal indicating how much power the RF generator 56 shouldoutput. The RF generator 56, in step 208, based on the reset power levelsignal, readjusts the power of the signal supplied to the cannula 28 andsupply electrode assembly 36 subassembly. Steps 302, 306 and 308 arethen continually reexecuted in order to ensure that the system 20 heatsthe tissue to which the cannula 28 is applied to the appropriatetemperature.

As mentioned above, in step 304, the proportional integral derivatealgorithm is employed to determine, based on the difference between themeasured, corrected and filtered temperature signal and thesurgeon-selected signal, the extent to which the RF power signal shouldbe adjusted. The proportional, integration and derivative constants forthe algorithm come from the PID data in the NVRAMs 154 and 155.Specifically, as part of the system configuration, step 304, in a step310, microcontroller 160 employs the PID values from the feedback loopdata field 210 of the electrode NVRAM_(E) 155 as the “base” PID values,step 190. In step 312, the PID multiplier values extracted from the PIDmultiplier field 216 of the cannula NVRAM_(c) 154 are selected asmultipliers. In step 314 the base PID values are multiplied by themultiplier values. The resultant products are the final PID values.These are the PID values employed in step 306 by the PID algorithm todetermine the extent to which the RF power signal should be reset. ThePID values may also come directly from the values contained in NVRAM_(c)154.

The electrosurgical tool system 20 of this invention is designed so thatonce an supply electrode assembly 36 is coupled to the control console22, the surgical personnel are presented with information thatidentifies the cannulae 22 that can be used with the electrode. Once acannula 28 is attached to the supply electrode assembly 36,microcontroller 160 determines if the cannula is appropriate.

Initially, this determination of cannula appropriateness is made bydetermining if the part number for the cannula is on tables that listacceptable and unacceptable cannulae. This provides a quick initialdetermination of whether or not the selected cannula is appropriate.Only if this evaluation does not reveal the appropriateness of thecannula 28, is a more detailed evaluation of appropriateness based onmatching the characteristics of the cannula to those of the electrodeexecuted. If this evaluation reveals that the cannula 28 is not anappropriate match for the supply electrode assembly 36, the surgicalpersonnel are presented with notice of this fact. Thus, system 20 bothprovides surgical personnel with a list of cannulae that can be attachedto the electrode so as to reduce the time needed to make thisdetermination and eliminates the possibility that surgical personnelcould unknowingly attach a cannula that is inappropriate for theelectrode.

Once a cannula 28 and supply electrode assembly 36 are coupled to thecontrol console 22, microprocessor 160 generates PID values for thecontrol algorithm used to regulate the power output by the RF generator156. These values are based on the PID values and PID multiplier valuesspecific to the attached cannula and electrode. Thus, the values may bespecific to the attached cannula and electrode so as to compensate formanufacturing differences of the individual components. Since the PIDvalues are generated automatically based on data read from the componentNVRAMs 154 and 155, the possibility that human error can result inincorrect values being input to the control algorithm is essentiallyeliminated.

It should be recognized that the above description is directed to onespecific version of system 20 of this invention. Alternative versions ofthe system may be possible. For example, in the described version of thesystem, the attached supply electrode assembly 36 is considered the“secondary” component. This is because once the supply electrodeassembly 36 is coupled to the control console 22, it is necessary toattach a cannula 28 with characteristics that match the electrode. Thus,the cannula 24 is the “primary” component.

In an alternative construction of system 20, the primary/secondary rolesof the components are reversed. This is accomplished, for example byproviding the cannula 28 with a radio frequency identification device(RFID) 320. In FIG. 20, RFID chip 320 is shown mounted in the cannulahub 46. This is exemplary. In some versions of the invention, RFID 320may be mounted in the package in which the cannula 28 is shipped. TheRFID 320 contains data substantially identical to the data contained inthe NVRAM_(c) 154. At the start of the procedure, the data in the RFIDare read. In FIG. 20 control console 22 is shown to have an RFID reader322 able to perform this function. Again, this is exemplary. The RFIDreader may be attached to pointer in the operating room used to readRFID 3200 as well as RFIDs integral with other devices and componentsused in the procedure. The data from RFID 320 is forwarded from thereader 212 to the console microcontroller 160.

Based on the data in the cannula RFID 320, microcontroller 160 generatesa list of electrodes that are appropriate for use with the cannula 28.Once a supply electrode assembly 36 is attached, microcontroller 160engages in a process similar to that described with reference to FIGS.22B-22C to determine if the selected supply electrode assembly 36 isappropriate.

VII. MONOPOLAR ELECTRODE ASSEMBLY

A monopolar electrode assembly of this invention is constructed out ofcomponents similar to the above described components. Specifically,there is a cannula that comprises the inner tube 48 with active tip 62and insulating sleeve 52. Hub 56 is attached to the proximal end of tube48. End 90 of terminal 86 abuts an exposed proximal end surface of innertube 48.

Monopolar electrode assembly of this invention includes a head unitvisually similar to the supply electrode assembly. However, in thisversion of the invention, shell 122 is not conductive. Instead, shell122 serves as an insulating housing for ensuring that the temperaturetransducer 120 is properly positioned relative to active contact 62.Thus shell 122 is a non-conductive post. Coupling assembly 116 is alsopart of this head unit.

A conventional ground pad is used as the return electrode for themonopolar version of this invention.

In this version of the invention, the electrical path between active tip62 and the control console is established by connecting the head unit tothe monopolar cannula. This coupling results in the proper position ofthe temperature transducer 120 to the active contact 62. This couplingalso results in the electrical connection of active tip 62 to thecontrol console through a conductor in cable 114. contact 140 of thehead unit and terminal 86 of the cannula assembly.

The above described arrangement thus means that the monopolar electrodeassembly of this invention is constructed so that the need to providethe head unit, which is reusable, with a shell that is conductive iseliminated. This serves to minimize the costs associated with makingthis assembly in comparison to those associated with providing reusablesupply electrodes wherein the associated shell is conductive.

With regards to NVRAMs utilized with the monopolar electrode assembly, amemory such as the NVRAM 340 is fitted in the ground pad proximal endplug (FIG. 20). The memory contains data that indicates thecharacteristics of the ground pad. The memory integral with monopolarcannula contains data that describes the characteristics of the groundpads that can be used with the cannula. These data identify acceptableground pads both by part number and physical characteristics. The datainclude for example, the minimum and maximum surface areas of theconductive portion of the ground pad and split versus solidconstruction.

As part of the configuration of the system for operation, themicrocontroller previously described of the control console 22 receivesfrom the ground pad memory data that describes the ground pad. Forexample, the plugging in of the ground pad to the console 22 connects aground pad NVRAM_(GP) to the NVRAM reader of the console 22.Microcontroller then performs an evaluation similar to that previouslydescribed in “VI Operation” section except to determine if the groundpad is appropriate for the cannula. As part of this evaluation, thecharacteristics of the supply electrode coupled to the cannula may beused as input variables. This process essentially eliminates thepossibility that system 20 can be configured for monopolar operationwith a cannula and ground pad that are inappropriately matched.

VIII. ALTERNATIVE EMBODIMENTS

Alternative versions of the invention are possible. For instance, theelectrically conductive outer tube 54 may also be an elongated memberhaving a circumferentially non-continuous strip (not shown) that carriesthe proximal end that is in electrical contact with terminal 86. Fromthe proximal end, the strip extends axially forward to the second activecontact 68 of the elongated member 54. Preferably, the contact 68 isring-shaped and thus circumferentially continuous with respect to axis50 for energy flux distribution in the tissue.

Further, the memories employed in the cannula 28 and supply electrodeassembly 36 of system 20 may be different than the described NVRAMs andRFID. There may be versions of the invention in which the appropriatememory integral with electrode is an RFID. Still other memory devices,such as optically read memories may be employed. These memory devicesinclude bar codes. In some versions of the invention, one or moreprecision resistors or mechanical keying may function as the memory forthe cannula and/or supply electrode.

Moreover, there is no requirement that in all versions of the invention,the match data that identifies an appropriate secondary component issolely data read from the memory from the primary component. In someversions of the invention, match data may be stored in look-up tableswithin the console memory 161. In these versions of the invention, theonly “match” data stored in the memory of the primary component is thepart number of the primary component. Based on this information,microcontroller 160 retrieves from memory 161 data that describe thematch characteristics of a component that can be coupled to the primarycomponent. These data include: lists of part numbers of secondarycomponents that can and cannot be mated with the primary component; anda list of acceptable characteristics of the secondary component.

Furthermore, there is no requirement that in all versions of theinvention, that the PID values be generated exactly as described. Insome versions of the invention, it may not be necessary to adjust thePID values retrieved from the electrode NVRAM_(E) 155 by multipliersfrom the cannula NVRAM_(c) 154. Also, in some versions of the invention,the PID values retrieved from the cannula NVRAM alone serve as the PIDvalues used to regulate power. Data fields in the cannula and supplyelectrode NVRAMs indicate if the PID values in the NVRAM are primaryvalues, values that in most instances are used, or secondary values,values that in certain predefined circumstances are substituted for theprimary values. Alternatively, the NVRAM data may indicate the PIDvalues are multipliers, PID values that are multiplied with the PIDvalues from the other component to obtain the final PID values.

The sequence of processes executed by the microcontroller to matchcomponents and configure the system is likewise only exemplary, notlimiting. Also, there is no requirement that, if it is determined that acannula 28 or supply electrode assembly 36 are unsuitable for use,control console 22 actually prevent the use of the component(s). Thus,after a determination of unsuitability is made, control console 22 maymerely present this information on the I/O module display. The surgeonwould then be required to acknowledge the determination and, then, thecontrol console 22 will energize the cannula 28 and supply electrodeassembly 36.

In still other versions of the invention, the components that supply thebase PID values and the PID multiplier values are different from theabove described versions of the invention. Thus, the data in NVRAMs 154,155, may indicate that, for a particular cannula 28 and supply electrode118, the cannula supplies the base PID values and the electrode the PIDmultiplier values. Hence, the microcontroller first reads the data inthe cannula and electrode memories to determine which of the twocomponents supplies the base PID values and which one supplies the PIDmultiplier values. Based on this determination, data from theappropriate fields internal to NVRAMs 154, 155 are read and multipliedto establish the PID values supplied to the control algorithm. Themultiplier may also be used to adjust system performance without theneed to reprogram the console.

There has been shown and described a unique design and concept of anelectrosurgical tool system. While this description is directed to a fewparticular embodiments, it is understood that those skilled in the artmay conceive of modifications and/or variations to the specificembodiments shown and described herein. Any such modifications orvariations which fall within the purview of this description areintended to be included herein as well. It is understood that thedescription herein is intended to be illustrative only and is notintended to be limited.

1. An electrode assembly comprising: a cannula having a first couplingassembly and an elongated tubular body having a proximal end mounted toa hub of the first coupling assembly and projecting outward to a distalend; first and second spaced apart and oppositely charged contactsdisposed adjacent to the distal end; a supply electrode having spacedapart proximal and distal ends, the supply electrode dimensioned to beslidably inserted in the body so as to be positioned to electricallycontact the first contact; a second coupling assembly attached to theproximal end of the supply electrode, the first and second couplingassemblies configured to releasably interlock; a first conductiveterminal seated in the hub and electrically connected to the secondcontact; and a second conductive terminal attached to the secondcoupling assembly, the first and second conductive terminals beingcollectively positioned so that when the coupling assemblies interlock,the conductive terminals abut.
 2. The electrode assembly set forth inclaim 1 further comprising: an inner tube of the body having the firstcontact; and a through-bore defined by and extending co-axially with theinner tube.
 3. The electrode assembly set forth in claim 2 wherein thesupply electrode is disposed at least in-part in the through-bore. 4.The electrode assembly set forth in claim 3 further comprising an outercylindrical shell of the supply electrode being in electrical contactwith an inner cylindrical wall of the inner tube.
 5. The electrodeassembly set forth in claim 4 wherein a clearance between the outercylindrical shell and the inner cylindrical wall is less than 0.001inches.
 6. The electrode assembly set forth in claim 3 wherein thethrough bore communicates through the distal end of the body.
 7. Theelectrode assembly set forth in claim 6 wherein the distal end of thesupply electrode is generally axially aligned to the distal end of thecannula when the first and second coupling assemblies are interlocked.8. The electrode assembly set forth in claim 7 further comprising atemperature sensor orientated in the supply electrode near the distalend of the supply electrode for measuring tissue temperature.
 9. Theelectrode assembly set forth in claim 7 further comprising first andsecond stops carried by the respective first and second couplingassemblies for maintaining consistent axial alignment of the distal endof the supply electrode with the distal end of the body.
 10. A cannulafor use with a matable supply electrode assembly having a couplingassembly connected to a cable that connects the supply electrodeassembly to a control console, said cannula comprising: an outer tubewith opposed proximal and distal ends and a through bore; an insulatingsleeve disposed over the outer tube and proximal to the distal end so asto provide a distal active contact; a hub attached to the proximal endof the outer tube, the hub dimensioned to releasably engage with thecoupling assembly; and a contact disposed in the hub for establishing aconductive path from the outer tube to a complimentary contact in thecoupling assembly.
 11. A cannula of an electrosurgical system having amatable supply electrode assembly for axial insertion into the cannuladuring a denervation procedure, said cannula comprising: an axis; anelectrically conductive and elongated outer member spaced radiallyoutward from the axis and extending axially forward to a first distalend of the outer member; an electrically conductive inner tube disposedconcentrically to the axis and radially inward from the outer member andextending axially forward to a second distal end of the inner tube; anelongated electrical insulating member disposed radially between andextending longitudinally with the inner tube and the outer member; andan axially extending through-bore is defined by the inner tube forreceipt of the supply electrode assembly.
 12. The cannula set forth inclaim 11 further comprising: a trailing proximal hub; a first proximalend of the conductive outer member in the hub; and a second proximal endof the conductive inner tube seated in the hub.
 13. The cannula setforth in claim 12 further comprising a flexible electrical terminalhoused in the hub and biased resiliently between the conductive outermember and an abutting terminal of the electrode assembly when thecannula is in the operational state.
 14. The cannula set forth in claim13 further comprising an inner cylindrical wall of the inner tube beingin electrical contact with the electrode assembly when the cannula is inthe operational state.
 15. The cannula set forth in claim 14 wherein theconductive outer member is an outer tube disposed concentrically to theinner tube and the insulating member is an insulating inner sleevedisposed concentrically to the inner tube.
 16. The cannula set forth inclaim 15 further comprising: an annular distal end of the inner sleevethat falls axially short of the second distal end of the inner tube; andwherein the second distal end is a second ring-shaped contact facingradially outward and exposed directly to the tissue.
 17. The cannula setforth in claim 16 wherein the annular distal end of the inner sleeve istapered for less obtrusive penetration by the cannula into the tissue.18. The cannula set forth in claim 16 further comprising an insulatingouter sleeve located radially outward from the outer tube.
 19. Thecannula set forth in claim 18 further comprising: an annular distal endof the outer sleeve that falls axially short of the fist distal end; andwherein the first distal end is a first ring-shaped contact spacedaxially rearward of the second ring-shaped contact by the insulatinginner sleeve and being directly exposed radially outward with thetissue.
 20. The cannula set forth in claim 19 wherein the annular distalend of the outer sleeve is tapered for less obtrusive penetration by thecannula into the tissue.
 21. The cannula set forth in claim 18 whereinthe insulating outer sleeve has an outer diameter of sixteen gauge orless.
 22. A method of operating a bipolar electrosurgical systemcomprising the steps of: penetrating tissue with a pointed tubular bodyof a cannula; locating the body to targeted tissue; inserting a supplyelectrode of a supply electrode assembly in a through-bore of the body;making electrical contact between a shell of the supply electrode and afirst electrode of the cannula that is exposed at least in part to thetargeted tissue; further inserting the supply electrode into thethrough-bore; and making electrical contact between a first terminalsupported by a first coupling assembly of the cannula and a secondterminal supported by a second coupling assembly of the supply electrodeassembly.